Kornimate/medical-research-clean huggingface dataset:
the effect of probiotics on low-grade inflammation, microbiota and risk factors for metabolic syndrome in obese children

Conditions: Metabolic Syndrome; Inflammation; Obesity

Summary: metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (ley et al., 2005). it has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (backhead et al, 2004). intervention study with overweight and normal weight school age children. the children will be randomised to receive selected probiotics or a placebo. fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. the dynamic of the microbiota of the gi will be monitored by molecular methods. markers of intestinal inflammation (calprotectin) and permeability will be analysed. blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. hypotheses this study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.


Eligibility criteria:
inclusion criteria: * 12-15 years * isobmi\>30 exclusion criteria: * chronical diseases * chronical medication
acute effects of chemotherapy administration on skeletal muscle of breast cancer patients: the protect-06 study

Conditions: Breast Cancer

Summary: chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. to date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. however, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both epuribicin/cyclophosphamide and paclitaxel chemotherapies on skeletal muscle of breast cancer patients.

chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. resulting from a global perturbation of the muscle homeostasis, skeletal muscle is characterized by both structural and functional alterations that will translate into a decrease in muscle mass and/or force as well as an increase in muscle fatigability. these maladaptations result in a reduced quality of life and an increased treatment-related toxicity, ultimately leading to an increased mortality risk.to date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. however, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue.our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both epuribicin/cyclophosphamide and paclitaxel chemotherapies on skeletal muscle of breast cancer patients. our study will particularly explore cellular mechanisms of muscle decontioning, such as protein turnover, mitochondrial homeostasis and fatty infiltrations.

Eligibility criteria:
inclusion criteria: * breast cancer (stade i to iii) * patient recieving the first administration of epirubicin-cyclophosphamide (group 1) or paclitaxel (group 2) for early breast cancer treatment exclusion criteria: * history of cancer * known chronic pathology * pacemaker * contraindication to the evaluation of the physical condition * contraindication to the local anesthesia for the muscle micro-biopsy * breastfeeding or pregnant woman

Keywords: protein turnover skeletal muscle deconditoning breast cancer chemotherapy muscle biopsy
efficacy of therapy with the spironolactone pills compared to minoxidil lotion in female pattern hair loss

Conditions: Female Pattern Hair Loss

Summary: this study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.


Eligibility criteria:
inclusion criteria: * subjects must be premenopausal women older than 18 with female pattern hair loss. exclusion criteria: * androgen excess * other scalp or hair disorders * contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs * contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats
paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in treating patients with advanced ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more tumor cells. purpose: this phase i/ii trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

objectives: primary * determine the maximum tolerated dose and recommended phase ii dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (phase i) * evaluate the efficacy of this regimen, in terms of ca-125 response rate after 6 courses of therapy. (phase ii) secondary * assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (phase i) * evaluate the safety profiles of this regimen in these patients. (phase i) * determine the objective response rate, as measured by recist criteria, in patients treated with this regimen. (phase ii) * determine the overall survival of patients treated with this regimen. (phase ii) * determine the overall response in patients treated with this regimen. (phase ii) * evaluate the safety and toxicity of this regimen in these patients. (phase ii) outline: this is a multicenter study. patients receive paclitaxel-loaded polymeric micelle and carboplatin.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed advanced ovarian cancer * measurable disease by recist criteria * no prior or concurrent cns metastasis patient characteristics: * ecog performance status 0-2 * life expectancy \> 6 months * clinically acceptable blood, kidney, and spleen function * not pregnant or nursing * fertile patients must use effective contraception * no preexisting sensory or motor neuropathy ≥ grade 1 * no other malignancies within the past 5 years prior concurrent therapy: * no prior chemotherapy for ovarian cancer * no prior immunotherapy or hormonal therapy for ovarian cancer * no prior radiotherapy to the pelvis or abdominal cavity * more than 2 weeks since prior major surgery other than debulking surgery

Keywords: stage iiia ovarian epithelial cancer stage iiib ovarian epithelial cancer stage iiic ovarian epithelial cancer stage iv ovarian epithelial cancer stage iiia ovarian germ cell tumor stage iiib ovarian germ cell tumor stage iiic ovarian germ cell tumor stage iv ovarian germ cell tumor
the effectiveness of intravenous txa on reducing perioperative blood loss for patients undergoing pao

Conditions: Bleeding

Summary: in this research study the investigators want to learn more about how a medication called tranexamic acid (txa) could help reduce bleeding during periacetabular osteotomy (pao) surgery. txa is approved by the food and drug administration (fda) for the reduction of bleeding for many types of surgical procedures. txa works by slowing the breakdown of blood clots and helps to prevent bleeding. from previous studies, txa has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries. as pao surgery has been associated with significant blood loss when compared to other types of joint surgeries. in order to try and avoid bleeding that may lead to complications, different strategies can be used. in this research study the investigators want to learn more about how a medication called tranexamic acid (txa) could help reduce bleeding during pao surgery.

this prospective randomized placebo controlled double blind trial will enroll 80 adolescents and young adults undergoing elective peri-acetabular osteotomy (pao). the primary aim is to determine if intravenous infusion of txa during surgery is effective compared to standard care (no txa) in decreasing blood loss (measured; and calculated) and blood transfusion (autologous and allogenic) perioperatively in adolescents and young adults presenting for pao surgery. the rate of blood loss over time will be measured and compared between groups with adjustment for length of surgery (time; hours) and body weight (kg).

Eligibility criteria:
inclusion criteria: * asa 1-2 * age 13-35 years * scheduled for primary unilateral pao +/- arthroscopy exclusion criteria: * hematologic disorder, thrombocytopenia (platelet count \<140,000/ul3) * major hepatic, renal, or vascular disorder * active thromboembolic disorder * color vision defect * txa allergy * taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel) * ethical and/or religious objection to receiving blood products * international patients * patients undergoing revision surgery * patients undergoing combined pao and other surgeries such as surgical dislocation, proximal femoral osteotomy

Keywords: tranexamic acid periacetabular osteotomy bleeding
enhanced recovery after radical cystectomy study

Conditions: Bladder Cancer

Summary: prospective non randomized study of two cohorts: usual protocol and the application of accelerated recovery protocol. f/up after discharge, 90 days and thereafter according to protocol of each center. compliance to be assessed.

this is a prospective non randomized study of two cohorts, one defined by the usual protocol and the other one by the application of accelerated recovery protocol. it's discarded a priori a prospective randomized trial, since it does not seem feasible to avoid byass of control group when synchronizing the active intervention and control. subjects surgery will be followed after discharge for a minimum of 90 days, and thereafter according to protocol of each center. patients will be provided with a satisfaction survey 90 days after surgery. the degree of compliance with the protocol will be assessed through a checklist indicating compliance with each of the steps of the protocol in both groups. all patients will sign an informed consent for the study authorizing the use of their clinical data for statistical analysis.

Eligibility criteria:
inclusion criteria: * consecutive patients scheduled for radical cystectomy in the participating hospitals * signed informed consent exclusion criteria: * refusal to sign informed consent
breakthrough improvement collaborative for colorectal cancer (bic4crc)

Conditions: Colorectal Cancer

Summary: colorectal cancer is the most common cancer in europe and the third worldwide. approximately 1 in 20 men and 1 in 35 women will develop colorectal cancer at some moment in their life. in flanders, in 2014, there was an increase in the detection of colorectal cancer with 21% compared to 2013. early detection improves the prognosis for the patient. in this early stage, colorectal surgery is one of the most important treatments, but it is also complex and has a high complication rate. however, over the last decade, surgical care for patients with colorectal cancer has become more standardized. the use of structured care methods, such as care pathways and protocols, has helped in standardizing care processes. specifically for patients with colorectal cancer, perioperative care has shifted with the implementation of enhanced recovery after surgery (eras) programs. the goal of eras- protocols is to optimize the interventions during the perioperative hospitalization period and reduce postoperative complications. despite the increasing evidence in favor of the use of these standardized protocols, adherence and implementation in daily practice remains challenging. the primary goal of this quality improvement project is to enhance the standardization of key interventions in the eras care process for patients undergoing colorectal surgery. therefore, adherence to the eras-guidelines will be investigated and hospitals will receive feedback to set up improvement initiatives. moreover, interactive group sessions and on-site training activities will stimulate knowledge sharing and define best practices.


Eligibility criteria:
inclusion criteria: * minimum age of 18 years * elective admission for colorectal cancer surgery exclusion criteria: * emergency (not planned) admission for colorectal cancer surgery * patients diagnosed with severe dementia or severe concomitant disease that may affect very short term outcome and hence influence deviations from standard acute care
oral vaccination against clostridium difficile infection

Conditions: Clostridium Difficile Infection

Summary: this clinical study is conducted to assess the safety and immunogenicity of a clostridium difficile vaccine (cdvax) in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. male 3. age: 18-50 years (limits included) 4. body mass index within 18.5 and 29.9 kg/m² 5. ability to read and comprehend study information 6. non-smokers or light smokers (\<4 cigarettes per day) 7. in good physical and mental health as determined by the following: 1. complete medical history 2. complete physical and neurological examination 3. vital signs including blood pressure, heart rate, respiratory rate, and temperature 4. standard 12-lead ecg 5. clinical laboratory (biochemistry, haematology and urinalysis) tests. blood and urine samples may be drawn up to 3 weeks prior to the baseline visit of the study provided all data are available and evaluated prior to administration of study drug. values of laboratory results outside normal reference ranges may be acceptable if the investigator considers that they do not compromise the safety of the subjects or the conduct of the study. 6. vital signs, clinical laboratory measurements, and ecg measurements may be repeated at the discretion of the investigator exclusion criteria: 1. evidence of c. difficile infection 2. anti-c. difficile (toxin a) immunoreactivity, suggesting previous c. difficile exposure 3. diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea 4. history of malignancy within 5 years 5. history of anaphylaxis, asthma or severe vaccine or allergic drug reaction 6. known or suspected history of immunodeficiency, active or inactive immune-mediated or inflammatory disease 7. receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the previous 30 days 8. vaccination within the previous 30 days (except for influenza vaccination) 9. blood or organ donation within the previous 60 days 10. evidence of clinically significant psychiatric, gastrointestinal, neurologic, neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the investigator) 11. use of prescription medication or regular use of over-the-counter medicines or herbal or dietary supplements. acetaminophen/paracetamol may be used intermittently as needed for pain 12. history or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse 13. positive hepatitis c antibody (hcv), hepatitis b surface antigen (hbsag) or positive human immunodeficiency virus (hiv)-1/2 antibodies 14. participation in any other investigational drug or device study within 60 days prior to the first study drug administration 15. relatives of, or staff directly reporting to the principal investigator 16. vulnerable subjects
pharmacokinetic study in healthy volunteers

Conditions: Healthy Volunteers

Summary: phase 1 clinical trial to evaluate insulin exposure using different formulations of technosphere insulin inhalation powder using the gen2 inhaler in healthy normal volunteers.

phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 u/mg and 4 u/mg technosphere insulin inhalation powder formulations administered using the gen2 inhaler in 31 healthy volunteers. drop outs will be replaced. each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

Eligibility criteria:
inclusion criteria: * non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy * body mass index (bmi) \< 32 kg/m2 * fev1 ≥ 80% of the third national health and nutrition examination survey (nhanes iii) predicted exclusion criteria: * pre-existing asthma or chronic obstructive pulmonary disease (copd) * history of coronary artery disease, peripheral vascular disease, or congestive heart failure * blood donation within the previous 3 months
pharmacogenomics of anti-tnf (anti-tumor necrosis factor) treatment in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the main aim of this study is to identify genetic markers (at dna and rna level) which are involved in the response to treatment with monoclonal antibodies against tnf in patients with rheumatoid arthritis.

rheumatoid arthritis (ra) is a severe inflammatory disease and genetic factors are known to play an important role in its pathogenesis. genetic factors are also involved in determining the prognosis of ra. identifying the genetic factors that predispose to mild or aggressive ra is not easy and up to now only a few of these factors -like certain hla-dr species- are known. the rheumatology department of the radboud university nijmegen medical centre (runmc) has collected a unique inception cohort of over 500 patients with ra, that have been followed from an early stage of disease for up to 10 years with detailed measurements of disease activity, joint damage and other characteristics of disease progression. in this project we use this patient group to study polymorphisms in a large battery of genes for their effect on ra disease activity/progression.

Eligibility criteria:
inclusion criteria: * patients with ra according to the acr criteria who are treated with monoclonal anti-tnf antibodies. exclusion criteria:

Keywords: rheumatoid arthritis pharmacogenetics anti-tnf high throughput genotyping
acoustic coordinated reset (cr®) neuromodulation for the treatment of chronic tonal tinnitus ("reset real life")

Conditions: Tinnitus

Summary: confirmation of efficacy and safety of acoustic cr®-neuromodulation for the treatment of chronic tinnitus patients using the ce marked anm t30 cr®-system in a real life outpatient setting. * identification of early indicators for therapy success * comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms * representative set of safety data in a broad patient spectrum * measurement of tinnitus burden (tbf-12 questionnaire) * generation of longterm compliance data


Eligibility criteria:
main inclusion criteria: * symptomatic subjective tonal chronical (\> 3 months) tinnitus * \<60db hearing loss * men and women ≥18 years old main exclusion criteria: * serious neurologic * psychiatric or internistic disease * objective tinnitus * morbus menière * craniomandibular triggered tinnitus

Keywords: acoustic cr®-neuromodulation anm t30 cr®-system
prospective clinical 5-year follow-up of the link® sp-cl® hip prosthesis stem

Conditions: Osteoarthritis, Hip; Femur Head Necrosis; Femoral Neck Fractures

Summary: the objective of this pmcf is to collect clinical and radiographic outcome information on total hip arthroplasty (tha) performed with link® sp-cl® hip prosthesis stem under routine conditions. the results collected will be used to clinically confirm the performance and safety of the link® sp-cl® hip prosthesis stem in terms of the manufacturer's obligation to perform a pmcf. furthermore the results can be used for future regulatory processes if needed.

post market clinical follow-ups (pmcf) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions \[2,3\]. against this background a prospective multi-center outcome study of the link® sp-cl® is planned.

Eligibility criteria:
inclusion criteria: * skeletally mature * subject agrees to comply with the required postoperative management and follow-up evaluations * undergone at least six (6) month of unsuccessful, conservative, non-surgical treatment * patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management. * patient signed informed consent. exclusion criteria: * body mass index (bmi) \> 40 kg/m2 * poor general state of health * acute and chronic infections, local and systemic * pharmaceutical or other drug abuse, alcoholism * allergies to implant materials * distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk * insufficient / inadequate bone mass- or quality which prevents a stable anchorage of the prosthesis * severe osteoporosis * foreseeable overload/ overstressing of the joint prosthesis * acetabular defects * female patient who is pregnant or plans to became pregnant during the course of the study * prisoner * patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule * patient who has not signed the informed consent

Keywords: pmcf post market clinical follow up sp-cl anatomic stem
drug-drug interaction study of esomeprazole (d961h) capsule and loxoprofen tablet after repeated oral administration in japanese males

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetic profile of esomeprazole (d961h) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of esomeprazole (d961h).


Eligibility criteria:
inclusion criteria: * healthy japanese male * body mass index (bmi=weight/height2) 19-27 (kg/m2) * body weight 50-80 kg exclusion criteria: * past or present nsaids induced asthma, hepatic dysfunction, peptic ulcer or blood disorders * significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s) , eg, acute inflammatory disease which requires medical intervention * past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction

Keywords: male japan japanese healthy volunteers